ProEd

ProEd Regulatory

Provaluate

Guiding teams through FDA Advisory Committee MeetingsFor More Than 20 Years

Combining sound science and strategy, effective communication, and operational excellence to get you to the summit of the regulatory landscape.

Guiding teams through FDA Advisory Committee Meetings For More Than 20 Years

Combining sound science and strategy, effective communication, and operational excellence
to get you to the summit of the regulatory landscape.

Guiding teams through FDA Advisory Committee Meetings For More Than 20 Years

Combining sound science and strategy, effective communication, and operational excellence
to get you to the summit of the regulatory landscape.

Regulatory Communications

Regulatory Communications

FDA Advisory Committee Preparation

FDA Advisory Committee Preparation

Since 1997, ProEd has helped more than 130 teams navigate the FDA Advisory Committee process with an 85% success rate. We help your team understand your audience, define strategies to address committee and agency concerns, craft a clear, concise, and compelling scientific story, and train and test your team to address the challenges of the day with confidence.

Strategy & Messaging

We help sponsors design a strategy to address committee members’ concerns and then build a scientifically valid and compelling story and key messages to highlight the strengths and overcome any weaknesses in your data package.

Intelligence & Insights

We help understand your committee members' mindset, how they’ve dealt with similar issues in the past, and the clinical landscape in which the data will be viewed.

Presentation Development

We help sponsors craft a scientifically credible and compelling story and communicate it effectively, building a presentation, narrative, and responses to questions that will resonate with your audience.

Briefing Document

Whether we write the document or provide an executive review, we’ll ensure that your briefing document is clear, concise, and aligned with your presentation.

Collaboration & Presentation Systems

Speaker Coaching

We train and test your team to deliver a consistent message and to handle the challenges of the day with confidence.

Mock Meeting Facilitation & Management

We will engage a panel of experts who mirror the potential advisory committee. We will challenge the team and facilitate discussions to build consensus and internalize critical feedback from the mock panel.

Project Management

Our proven project management approach has been built on 20 years of best practices, and our processes are purposefully designed to achieve a trajectory of continuous progress.

Strategy & Messaging

We help sponsors design a strategy to address committee members’ concerns and then build a scientifically valid and compelling story and key messages to highlight the strengths and overcome any weaknesses in your data package.

Intelligence & Insights

We help understand your committee members' mindset, how they’ve dealt with similar issues in the past, and the clinical landscape in which the data will be viewed.

Presentation Development

We help sponsors craft a scientifically credible and compelling story and communicate it effectively, building a presentation, narrative, and responses to questions that will resonate with your audience.

Briefing Document

Whether we write the document or provide an executive review, we’ll ensure that your briefing document is clear, concise, and aligned with your presentation.

Collaboration& Presentation Systems

Speaker Coaching

We train and test your team to deliver a consistent message and to handle the challenges of the day with confidence.

Mock Meeting Facilitation & Management

We will engage a panel of experts who mirror the potential advisory committee. We will challenge the team and facilitate discussions to build consensus and internalize critical feedback from the mock panel.

Project Management

Our proven project management approach has been built on 20 years of best practices, and our processes are purposefully designed to achieve a trajectory of continuous progress.

Strategy & Messaging

We help sponsors design a strategy to address committee members’ concerns and then build a scientifically valid and compelling story and key messages to highlight the strengths and overcome any weaknesses in your data package.

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Intelligence & Insights

We help understand your committee members' mindset, how they’ve dealt with similar issues in the past, and the clinical landscape in which the data will be viewed.

Presentation Development

We help sponsors craft a compelling story and communicate it effectively, building a presentation and narrative that will resonate with your audience, as well as writing a clear and concise briefing document that is aligned with your presentation.

Briefing Document

Whether we write the document or provide an executive review, we’ll ensure that your briefing document is clear, concise, and aligned with your presentation.

Collaboration & Presentation Systems

Speaker Coaching

We train and test your team to deliver a consistent message and to handle the challenges of the day with confidence.

Mock Meeting Facilitation & Management

We will engage a panel of experts who mirror the potential advisory committee. We will challenge the team and facilitate discussions to build consensus and internalize critical feedback from the mock panel.

Project Management

Our proven project management approach has been built on 20 years of best practices, and our processes are purposefully designed to achieve a trajectory of continuous progress.

Submission Readiness

Health Authority Meeting Support

We apply our proven process to help you prepare for your critical regulatory meetings–from EU Oral Hearings, to end-of-phase or pre-NDA meetings.

Strategic Regulatory Communication

Our strategic approach to briefing documents, white papers, orphan applications, and other key regulatory communications can help you better anticipate concerns and develop a more effective dialog with regulators.

EXPLORE OUR CASE STUDIES

Over time, we have amassed a wealth of experience that we apply to our services within the regulatory space. We combine this expertise to custom tailor solutions that fulfill your goals and objectives.

Overcoming Concerns to Secure FDA Approval

How can a biotechnology company overcome concerns about clinical benefit
and tolerably to secure FDA approval of an extended adjuvant cancer treatment?

Overcoming Concerns to Secure FDA Approval

How can a biotechnology company overcome concerns about clinical benefit
and tolerably to secure FDA approval of an extended adjuvant cancer treatment?

Multiple-indication Approval with Data from One Clinical Trial

How can a biosimilar company overcome concerns about extrapolation across indications to secure a multiple-indication approval with data from only one clinical trial?

Multiple-indication Approval with Data from One Clinical Trial

How can a biosimilar company overcome concerns about extrapolation across indications to secure a multiple-indication approval with data from only one clinical trial?

REQUEST MORE INFORMATION

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